Current Status of Stevia Mark D. Gold
------------------------ October 3, 1995
Stevia is widely used as a sweetener in Japan (~40% of the sweetener market),
Brazil, South Korea, Paraguay, and a number of other countries. There has never
been a report of an adverse reaction linked to the use of Stevia.
In the early and mid 1980s, Stevia was growing in popularity. During the last
part of the 1980s, the FDA began seizing Stevia from health food manufacturers
without adequate explaination. In 1990, Food Processing magazine had an insert
about stevia. Approximately 200 manufacturers including all of the major food
manufacturers showed interest in using Stevia in the manufacturing of their
products.
In 1991, the FDA banned the importation of Stevia intended for use in foods.
This ban was reportedly at the request of NutraSweet (owned by Monsanto) which
produces a toxic artificial sweetener called aspartame. This action, a clear
violation of the law which allows any product with a history of safe use before
1958 to be automatically approved, kept manufacturers from using stevia and
kept NutraSweet from having to compete with a safe, "natural" sweetener.
In 1992, the American Herbal Products Association (AHPA) petitioned the FDA to
declare use of Stevia as GRAS (Generaly Recognized As Safe). The AHPA provide
hundreds of documents showing that Stevia had been commonly and safely used
before 1958, and thus met the requirements for GRAS status. In July, 1992 the
FDA rejected the AHPA petition. When asked how much more information was needed,
the FDA responded "Well, this may sound flippant, but we'll know it when we see
it."
(Translation: No matter what you provide we're not going to approve stevia to
compete with artificial sweeteners.)
After exchanges of letters and a meeting, the FDA demanded information that they
do not have the authority to request and they demanded information based on
proposed regulations that they did not pass. Still, in the spirit of
cooperation,
the Herbal Research Foundation provided additional information requested about
the safety and use of stevia.
In December 1993, the FDA again disallowed the filing of the AHPA petition for
approval of Stevia. This meant that public comment on the petition by
qualified experts could not take place and that stevia would not be approved.
In September 1995, the FDA adjusted their "Import Alert" to allow for the
importation of Stevia *only* if it is clearly marked that it is intended to be
used as or in dietary supplements. This will tend to permit personal use, but
keep food manufactuers from using Stevia in their products until they can be
secure in their supply for all intended uses.
Thus, the FDA is still in clear violation of the law (which, by the way, means
nothing to the FDA when it comes to protecting their "clients," i.e., Monsanto/
NutraSweet), but at least it is a small step in the right direction.
Below is a copy of the updated Import Alert. The FDA's statements about the
inadequacy of Stevia's safety testing is irrelevant and ridiculous. See
petitions to the FDA.
------------------------
Date: Sun, 1 Oct 1995 11:30:20 -0400
From: bbs@www.fda.gov (BBS Users )
Message-Id: <9510011530.AA11735@www.fda.gov.fda.gov>
X-Within-Url: http://www.fda.gov///ora/fiars/ora_import_ia4506.html
To: mgold@holisticmed.com
Subject: ora_import_ia4506.html
IA#45-06, REVISED 9/18/95, ----ATTACHMENT 9/18/95
SUBJECT: "AUTOMATIC DETENTION OF STEVIA LEAVES, EXTRACT OF STEVIA LEAVES, AND
FOODS CONTAINING STEVIA"
NOTE : This alert has been revised to clarify guidance for
products containing stevia intended for use as a dietary
supplement and create an attachment to identify products
that have been found to contain stevia or stevioside.
Additional changes are bracketed by asterisks (***).
TYPE OF ALERT : Automatic Detention
***(Note: This import alert contains guidance to FDA
field personnel only. It does not establish any
requirements or obligations on FDA or on regulated
entities.)***
PRODUCT : Stevia Leaves, Stevioside (Extract of Stevia Leaves),
Foods containing Stevia, ***unless explicitly labeled as
a dietary supplement or for use as a dietary ingredient
of a dietary supplement.***
PRODUCT CODE : 45T[][]99
All food product codes where the leaves or Stevioside are
present as an ingredient ***(except for dietary
supplements).***
HARMONIZED
CODE : 0712.[][].[][][][]
PROBLEM : Unsafe food additive
PAC : 09006A
COUNTRY : See attachment
MANUFACTURER/
SHIPPER : See attachment
MANUFACTURER/
SHIPPER
I.D.# : N/A
IMPORTERS
I.D. # : N/A
CHARGE : "The article is subject to refusal of admission pursuant
to Section 801(a)(3) in that it appears to contain a food
additive which is unsafe within the meaning of Section
409, namely Stevia leaves or the extract thereof
(Stevioside) [Adulteration, Section 402(a)(2)(c)].
RECOMMENDING
OFFICE : DAL-DO (HFR-SW140);
***CFSAN/Office of Special Nutritionals/Regulatory
Branch, (HFS-456);
CFSAN/Office of Field Programs/Import Programs Branch,
(HFS-637)***
REASON FOR
ALERT : Stevia leaves are a native product in Brazil and
Paraguay. The extract, stevioside, has reportedly been
approved for use in foods in Brazil and Japan. The
product is used in these countries as a table-top
sweetener in virtually all food commodities and as a
flavor enhancer in such products as teas. Stevioside is
reportedly 250-300 times sweeter than sugar and
contributes no calories to the diet.
***With regard to its use in foods, stevia is not an
approved food additive nor affirmed as GRAS in the United
States. Available toxicological information on stevia is
inadequate to demonstrate its safety as a food additive
or to affirm its status as GRAS. However, with regard to
its use in dietary supplements, dietary ingredients,
including stevia, are not subject to food additive
regulations.
Stevia leaves and stevioside have been offered for entry
both in bulk and in finished products. Examples of
products detained because of stevia include teas, drinks,
seafood, fruits, vegetables, and candies. FDA analysis
performed by Dallas district found diet teas to consist
of up to six percent of stevioside.***
GUIDANCE : ***Districts may detain without physical examination all
products identified on the attachment to this alert. If
review of the labeling or import paperwork reveals stevia
leaves, stevioside, or products containing stevioside,
districts may detain these items without physical
examination, unless explicitly labeled as a dietary
supplement, or for use solely as a dietary ingredient in
the manufacture of a dietary supplement product.
If stevia is to be used in a dietary supplement for a
technical effect, such as use as a sweetener or flavoring
agent, and is labeled as such, it is considered an unsafe
food additive. However, in the absence of labeling
specifying that stevia is being or will be used for a
technical effect, use of stevia as a dietary ingredient
in a dietary supplement is not subject to the food
additive provisions of the FD&C Act.
If districts determine through analysis that a product
contains stevia leaves or stevioside, recommendations for
automatic detention should be forwarded to DIOP, HFC-170,
with the analytical package unless the product is
explicitly labeled as a dietary supplement or for use
solely as a dietary ingredient in the manufacture of a
dietary supplement product.
In FY'95, there have been several shipments of pickled
radishes from Japan detained because of presence of
stevioside. Also, in recent years stevia has been found
in many seafood products from Japan. Districts should
consider sampling these products for the presence of
stevioside if its presence cannot be determined from the
label.***
Stevia leaves/stevioside may be under study in the United
States in research settings as a basis for establishing
toxicological information for future food additive
petitions. As stevia leaves/stevioside are not available
in the United States, imported shipments of stevia
leaves/stevioside may be considered for release when
documentation exists to demonstrate that the pending
destination and use of the product is for research
purposes.
***For questions or issues concerning science, science
policy, sample collection, analysis, preparation, or
analytical methodology, contact the Division of Field
Science at (301)443-3320 or 3007.***
PRIORITIZATION
GUIDANCE : II
FOI : No purging required.
KEYWORDS : Stevia, stevioside, sweetener, flavor enhancer, unsafe
food additive
DATE LOADED
INTO FIARS : September 18, 1995
ATTACHMENT TO IMPORT ALERT #45-06 REVISED 9/18/95
SPECIFIC FIRMS AND PRODUCTS IDENTIFIED FOR AUTOMATIC DETENTION
JAPAN (JP, 490)
FIRM: PRODUCT: AUTO DET: PRODUCT CODE:
Kuroda Shokuhin Pickled Radish 9/18/95 25J[][]26
Co., Inc.
Kobe City, Hyogo, Japan
MID# JPKURSHO1511KOB